Responsivity and reproducibility of messenger and micro RNA airway inflammatory markers - a pilot study

Responsivity and reproducibility of messenger and micro RNA airway inflammatory markers - a pilot study - mRNA and miRNA airway inflammatory markers - a pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50575

Enrollment

Registered

2017-11-14

Start date

2018-04-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >40 years at recruitment - COPD patients with an FEV1/FVC 0.8 L and ability to produce sputum after hypertonic saline production - A smoking history of >10 pack years

Exclusion criteria

Exclusion criteria: - Acute pneumonia as determined by X-ray - > 48 h intake of prednisolon/antibiotics - Need for mechanical ventilation (either invasive or non-invasive) - Treatment with immune-modulating agents for any disease - Experimental interventions for COPD last half year - Former/concomitant diagnosis of asthma - Any significant other pulmonary disease or disorder - Existing pregnancy/ current willingness for becoming pregnant

Design outcomes

Primary

Measure	Time frame
Primary endpoints of induced sputum samples: The main parameters of induced sputum samples will be mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta. Primary endpoints of nose mucosa samples: The main parameters of nose mucosa samples will be mRNA and miRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta. Therefore, three consecutive sputum inductions and nasal brush extractions will take place in a 7 week period. The obtained data from Visit 1 and 2 will used to analyze the responsivity of these inflammatory markers during a marked change in inflammatory state. The obtained data from Visit 2 and 3 will be used for the analysis of reproducibility of these inflammatory markers.	—

Measure

Time frame

Primary endpoints of induced sputum samples: The main parameters of induced sputum samples will be mRNA level expression of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta. Primary endpoints of nose mucosa samples: The main parameters of nose mucosa samples will be mRNA and miRNA level expression of IL-6, IL-8, IL-17, TNF-alpha, MCP-1, MIP-1 beta and TGF-beta. Therefore, three consecutive sputum inductions and nasal brush extractions will take place in a 7 week period. The obtained data from Visit 1 and 2 will used to analyze the responsivity of these inflammatory markers during a marked change in inflammatory state. The obtained data from Visit 2 and 3 will be used for the analysis of reproducibility of these inflammatory markers.

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Secondary

Measure	Time frame
The following parameters will be investigated for our secondary objectives in induced sputum of COPD patients: - Inflammation cell profiles - LTB4 levels - protein levels of IL-6, IL-8, TNF-alpha, MCP-1, MIP-1 beta, ECP and TGF-beta	—

Countries

Netherlands

Outcome results